ANNUAL REPORT 2017 · 2019-05-17 · The Chemistry Laboratory received turmeric powder for testing from the ISDH Food Protection Program (sample source from Indian market); the sample

ANNUAL REPORT

2017

Contact Us

[email protected]

317-921-5500

550 W. 16th St. Suite B

Indianapolis, IN 46202

Indiana State Department

of Health Laboratories

2

TABLE OF CONTENTS

Message from the Director __________________________________________ 3

Financial Report ____________________________________________________ 4

Funding Sources _______________________________________________________________ 4

Laboratory Expenses ___________________________________________________________ 5

Staffing _____________________________________________________________ 6

Welcome New Staff!____________________________________________________________ 6

Farewell to Kathy Carroll: 3 Years of Excellence __________________________________ 7

Year at-a-Glance ___________________________________________________ 8

Lab Innovations ____________________________________________________ 12

Chemistry Laboratories _____________________________________________ 14

Biological Preparedness and Outreach _____________________________ 16

Environmental Microbiology ________________________________________ 20

Virology/Serology _________________________________________________ 21

Clinical Microbiology ______________________________________________ 23

Quality Assurance _________________________________________________ 26

Protecting the Health of Hoosiers ____________________________________ 27

3

MESSAGE FROM THE DIRECTOR

Dear Public Health Partners:

The Indiana State Department of Health Laboratory moved into its present light,

airy, and comfortable building in March 2007. That was also one month before yours truly

took the Deputy Director position at the lab, thus missing the challenges and agonies of preparing for,

and executing, the big move. I will always be grateful for that fortuitous timing! Looking at the lovely

and clean surroundings, I remember thinking, “I wonder how long this will last.” Fortunately, the

building looks just as good as it did back then, thanks to the excellent management of REI Real Estate

Services and Margi Johnson, our facility manager, and her staff. This year we threw a lab party on the

tenth anniversary of the move and honored Margi with a plaque and gift of appreciation.

The notable outbreaks and high-level public health threats to which the lab responded in 2017

included the threat of Zika virus infection and lead

poisoning of residents living on a Superfund Site in

northwest Indiana. Public awareness of lead in water

after the Flint, Michigan, situation resulted in investigations

and responses to perceived threats in several Indiana

school districts. Lab chemistry and outreach staff worked with our environmental health and the new

ISDH Lead and Healthy Homes Division as well as our Preparedness Division to provide lead testing of

both water and children in affected areas.

Again in 2017, members of our lab staff were honored with prestigious national recognition

awards and elected leadership positions. Jessica Gentry, TB Lab Supervisor, was recognized nationally

at the 2017 TB Conference for her exceptional service. She also was awarded the Ed Desmond

Laboratorian award at that meeting. Dr. Sara Blosser and Jessica Gentry were among ISDH staff

awarded the CDC’s Shepard Award for their role in responding to the Scott County HIV outbreak.

Jessica and Dr. Blosser, as well as Dr. Nicolas Epie and Brian Pope, took on additional leadership

positions in their respective national organizations.

Lab staff led numerous local public health and leadership activities, including providing

valuable public health trainings in phlebotomy and detection of multidrug antibiotic resistance.

Our lab’s International influence continued as an ASM/CDC Global Fellowship sponsored

seven scientists and two interpreters from Armenia, Kazakhstan, and Georgia to visit the ISDH

Laboratories to observe Quality Management Systems in place, especially internal auditing and

analyst competency. They provided high praise for our demonstrations.

It continues to be my honor and pleasure to lead this outstanding group of laboratory

scientists.

“It continues to be my

honor and pleasure to lead

this outstanding group of

laboratory scientists.”

4

FINANCIAL REPORT

Funding Sources

The Indiana State Department of Health Laboratories receives its funding from federal and state

sources. However, the majority of funding the laboratory receives comes from the state.

Federal funds are drawn from U.S. grants awarded by federal government agencies such as the Food

and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), a division of

the Department of Health and Human Services. Examples of these grants are the Public Health

Emergency Preparedness (PHEP) and Epidemiology and Laboratory Capacity (ELC) grants.

$5,709,195

$1,231,945

$288,101

$2,151,642

$802,648

$931,916

$557,670 $255,000

2017 Sources of Funding

State General Fund Federal Project

Reimbursement/Billing Fund PHEP Grant

Other Federal Funds ELC Grant

HIV/STD Testing Fund IDEM

5

Laboratory Expenses

The two figures below represent a summary of total laboratory expenses for 2017, as well as tests per

who we served in 2017.

$6,478,800.90

$123,708.65

$655,028.81

$1,929,732.63

$1,150,122.84 $292,329.91 $29,749.49

Total Laboratory Expenses

PERSONNEL & CONSULTANTS UTILITIES CONTRACTUAL

SUPPLIES EQUIPMENT OTHER OPERATING COSTS

INDIRECT COSTS

BOAH, $711,710,

16%

CDC, $309,786, 7%

DOC, $652,963,

15%

Public Water

Systems, $64,811,

2%

IDEM, $701,974,

16%

ISDH, $1,366,718,

31%

LHD, $361,904, 8%

Other Agencies,

$152,372, 4%

Private Wells,

$61,252, 1%Who We Served in 2017

6

STAFFING

Welcome New Staff!

Tracy Feeney, Food Microbiology Laboratory Robin Williams, Media Preparation Laboratory

ISDH Laboratories Staff by Division (total = 95 employees)

Virology/Serology

Administration

Clinical Microbiology

Environmental Microbiology

Biological Preparedness, Laboratory Outreach and Logistics

Chemistry

7

Carley Carroll, Assay Development Laboratory Shreelakshmi Gopal, Biowatch Laboratory

Angela Lucas, Serology Laboratory

Farewell to Kathy Carroll: 3 Years of Excellence

In December and after three years of service as the ISDH Laboratories

Administrative Assistant, Kathy Carroll transferred to the Adjutant General’s Office

as their new Purchasing Administrator. Kathy has been with the State of Indiana

nearly ten years and began in the ISDH Human Resources Department until it was

absorbed by Indiana State Personnel Department. Since then she has worked for

the Indiana Department of Workforce Development and as the Facilities

Coordinator for the ISDH Administrative Services Department before transferring to

the laboratories in 2014. Kathy provided administrative assistance to Dr. Judy

Lovchik, Dr. Kate Wainwright, and other senior staff at ISDH Laboratories. She also

served as the laboratories’ travel liaison, provided support to the Outreach and Training Team, and

helped coordinate special events for the laboratories. ISDH Laboratories would like to recognize

Kathy’s dedication to the agency, her strive for excellence, and her warm friendship. She will be

missed. Thank you, Kathy Carroll, for three years of excellence at ISDH Laboratories!

8

YEAR AT-A-GLANCE

JANUARY

A consumer complaint sample of purchased pediatric water

received by the Chemistry Laboratory contained isopropyl

alcohol from an unknown source.

Reference Microbiology identified a Capnocytophaga species

from the blood of a 59-year-old female, isolated

Achromobacter species from a rectal swab, and identified an

OXA-48-like E. coli specimen.

The Dairy/Meat testing laboratory attended the annual FDA Laboratory Accreditation meeting

required for the FDA ISO grant.

The Virology Laboratory had an increased number of influenza positives (predominantly

influenza A/H3) and tested three specimens positive for mumps.

FEBRUARY

The Food Chemistry Laboratory’s ISO 17025 audit went well; only minor deficiencies were

found.

Testing was made available for Carbapenem Resistant Pseudomonas aeruginosa. A letter was

sent to select facilities announcing this pilot study, which is being funded by the CDC’s

Antibiotic Resistance Lab Network (ARLN).

The Food Microbiology Laboratory’s L-A-B (ANAB) audit was completed; no deficiencies were

found.

The Serology Laboratory started HIV confirmatory testing using the Biorad-Geenius.

MARCH

The Chemistry Laboratory accepted fish samples for analysis of histamine due to a scombroid

poisoning incident affecting students from Notre Dame. The laboratory analyzed eight fish

samples, and one sample was positive for histamine at approximately 150 ppm.

Thirteen Carbapenem-Resistant Pseudomonas aeruginosa isolates were tested as part of the

CRPA pilot study.

The Environmental Microbiology Laboratory attended the PulseNet Regional Meeting, the

STARLIMS Configuration Training, a CDC workshop on Algorithms in Molecular Parasitology, the

South Central Association for Clinical Microbiology Annual Spring Meeting, and the Indiana

Branch of American Society for Microbiology (ASM) annual meeting.

9

APRIL

Jessica Gentry, TB Laboratory Supervisor, was recognized nationally at the 2017 TB Conference

for her exceptional service and was awarded the Ed Desmond Laboratorian Award. This

award honors exemplary service, dedication, or leadership to a TB laboratory professional.

Jessica presented a poster and conducted a presentation, “Equivocal TB Smears,” at the

conference. She also presented two lectures at the CDC’s Diagnostic Mycobacteriology

Workshop.

The Chemistry Laboratory continued to receive blood lead and drinking water samples from

East Chicago. The drinking water samples were collected for lead and ortho-phosphate

testing.

Jamie Yeadon-Fagbohun, Enteric Laboratory Supervisor, participated in ISDH’s National Public

Health Week Open House and presented a poster, “Why Was My Specimen Cancelled?,” at

the ISDH Public Health Nurse Conference.

MAY

The Indiana Department of Environmental Management (IDEM) sent a letter to all public water

supplies stating radiochemistry testing had become a fee-for-service test.

The Antibiotic Resistance Laboratory Network started implementing Carbapenem-Resistant

Enterobacteriaceae electronic reporting.

One specimen tested positive for mumps in the Virology Laboratory.

JUNE

The Chemistry Laboratory received a new mercury analyzer.

The Clinical Microbiology Division Director, Dr. Sara Blosser, was introduced to the American

Board of Medical Microbiology (ABMM) as one of the new diplomates. She also was awarded

the CDC’s Shepard Award, alongside TB Laboratory Supervisor Jessica Gentry, for a publication

regarding their contributions to the Scott County HIV outbreak.

The Food Microbiology Laboratory provided outstanding service and received a certificate of

appreciation from the Illinois Department of Agriculture for providing meat sample testing

during the Illinois laboratory’s move.

Several ISDH laboratorians attended the Association for Public Health Laboratories (APHL)

annual meeting in Providence, Rhode Island.

10

JULY

The Food Chemistry Laboratory received a sample of breast milk from a mother who had an

elevated blood lead level (13 ug/dL). The concern was her milk was contaminated and being

transferred to her baby. The analysis resulted in approximately 20 ppb of lead in the mother’s

milk. If the milk were water, it would be over the Safe Drinking Water limit.

ISDH Laboratories received $343,894 in CDC Epidemiology and Laboratory Capacity (ELC)

grant funding to support Whole Genome Sequencing (WGS), PFGE, and Norovirus testing.

One specimen received by the Virology Laboratory tested positive for Varicella Zoster Virus

(VZV).

AUGUST

The Chemistry Laboratory analyzed 70 well water samples from the Morgan County Fair for

lead/copper/arsenic. Five out of 70 samples were high for lead, one was high for copper, and

14 were high for arsenic.

One Streptococcus pneumoniae isolate was submitted/serogrouped as part of the Indiana

Communicable Disease Rule. This isolate was typed as serogroup 19A, which is vaccine-

preventable.

The Water Microbiology Laboratory received its Environmental Protection Agency (EPA) Audit

report from the 2016 onsite audit; the laboratory did not have any deficiencies.

The Virology Laboratory received its first flu positive of the flu season; PCR was performed and

the specimen result was Influenza A/H3.

SEPTEMBER

The second of the two SEAL Analytical Autoanalyzers was installed; phosphorus, chloride,

sulfate, and cyanide testing are now on the system.

The Clinical Microbiology Division Director was asked to sit on a Council of State and Territorial

Epidemiologists (CSTE) Workgroup for the AR Resistance Surveillance Task Force. This workgroup

will identify and recommend strategies to improve the communication of standardized and

timely information on AR from laboratories to public health.

The Enteric/Parasitology Supervisor attended the FDA’s WGS and GenomeTrkr workshop.

The Virology Laboratory received a specimen that was positive for dengue virus.

11

OCTOBER

The Chemistry Laboratory received turmeric powder for testing from the ISDH Food Protection

Program (sample source from Indian market); the sample contained 675 ppm lead.

An isolate submission guide was developed for Streptococcus pneumoniae serotyping requests

for patients ages 6 – 12. This submission guide is on the ISDH website.

The Virology Laboratory received three specimens positive for Influenza A/H3 and one

specimen positive for Influenza B/Yamagata.

NOVEMBER

ISDH Laboratories and Epidemiology Resource Center (ERC) investigated a Mycobacterium

chelonae case, which was related to injection practices in a podiatry office.

Several ISDH Laboratories staff attended the CDC InFORM conference in Garden Grove,

California. Posters presented included “Not this child again! A Shift in PFGE Pattern Observed

Following a 13-week Exclusion of Daycare Attendee” and “Enhanced Communication:

Continual Improvement to Indiana’s Rapid Response Team.”

The Virology Laboratory received one positive measles specimen and one specimen positive

for hantavirus.

DECEMBER

Medicaid’s Early and Periodic Screening, Diagnosis and Treatment (EPSDT)/Healthwatch was

updated; blood lead testing requires a confirmatory venous sample if the capillary result is over

5 mg/dl. This aligns with the recommendations by the American Academy of Pediatrics.

ISDH Laboratories began providing arsenic speciation to private citizens for $80 per drinking

water sample. This has enhanced the ability of citizens to treat their well water for high levels of

naturally occurring arsenic.

12

LAB INNOVATIONS

CDC, 1963

New Instruments:

Roche MagNA Pure 96 and bioMerieux eMAG systems for high throughput nucleic acid

extraction

Illumina MiSeq for whole genome sequencing

QIAGEN QIAcube for automated nucleic acid extraction in the Food Microbiology Lab

LECO Protein Analyzer for food protein analysis

Hologic Panther instrument for CT/GC testing for male urine, vaginal, endocervical, and

urethral specimens

bioMerieux GENE-UP PCR system for the Food/Dairy/Meat Microbiology Laboratory

QIAGEN QIAxcel for the Enteric/Parasitology/Molecular Subtyping Laboratory

SEAL Analytical Autoanalyzer for phosphorus, chloride, sulfate, and cyanide tests

Ion Chromatograph for bromide, chloride, sulfate, and other anion analyses in water

Validations/Verifications:

Yeast MALDI-TOF validation

Staphylococcus MALDI-TOF Library verification

mCIM validation to detect the phenotypic production of carbapenemases

Sensititre validation

CSR Bead validation for 90-day extension of expiration date in the Food/Dairy/Meat

Microbiology Laboratory

CDC PulseNet certification and in-house verification for molecular subtyping of Vibrio

cholerae and Vibrio parahaemolytics via pulsed field gel electrophoresis (PFGE)

13

New Testing Methodologies:

A method comparison proposal was submitted, completed, and approved for the

transition of Auramine O-phenol microscopy to Kinyoun staining for the confirmation of

MGIT positive tubes.

The Serology Laboratory started HIV confirmatory testing using the Biorad-Geenius.

One run of WGS CP-CRE specimens was successfully completed and ready for analysis.

In addition, the methodology for the gene-to-gene homology comparison was

investigated and an analysis plan developed. This plan will primarily focus on

comparing genes of antibiotic resistance to aid in outbreak analysis and investigation.

Staff participated in several troubleshooting exercises to bring on Disk Diffusion

Antimicrobial Susceptibility Testing as part of the ELC ARLN activities.

Assay Development received a panel of Legionella isolates for WGS as part of a

collaborative project with the CDC.

The KPC typing assay project was initiated.

A THC method was tested by the Food Chemistry Laboratory for possible testing of

hemp oil supplements.

The testing for the CA MALDI-TOF method comparison was completed and will expand

the extraction methods acceptable for use with the CA MALDI-TOF system.

US PH Service, 1935

14

CHEMISTRY LABORATORIES

With five testing areas (Inorganic, Organic, Metals, Radiochemistry, and Food), the Chemistry

Laboratory routinely performs analytical testing on soil samples, food, meat, and dairy products;

environmental and blood lead samples; and multiple other water sources. In 2017, the Chemistry

Laboratory processed approximately 66,725 tests supporting local health departments (LHDs), private

citizens, IDEM, the Indiana Department of Natural Resources (DNR), Indiana State Board of Animal

Health (BOAH), Indiana Department of Homeland Security (IDHS), private and public water systems,

and other ISDH programs (e.g. Food Protection, Environmental Public Health, Lead and Healthy

Homes, and Emergency Preparedness).

45177

10341

584 5963002 7024

2017 Chemistry Testing Volume

General/Inorganic Chemistry Metals

Organic Chemistry Radiochemistry

Food Chemistry Blood Lead

15

Roses are Red; Violets are Blue; Cyanobacteria are Blue-green and Can Be Harmful

to You!

Blue-green algae, also known as

cyanobacteria, can be found in various

salt and freshwater ecosystems and are

typically not problematic. However,

under certain environmental conditions,

they can quickly multiply to form harmful

algal blooms and produce toxins

(cyanotoxins). Exposure to these toxins

can affect the human central nervous

system (neurotoxin), the human liver

(hepatotoxin), or human skin

(dermatoxin). According to the EPA, the

most common cyanotoxins include

microcystins (produces hepatotoxins), cylindrospermopsin (produces hepatotoxins), anatoxins

(produces neurotoxins), and saxitoxins (produces Paralytic Shellfish Poisoning, PSP, toxins).1 Both

humans and pets, such as dogs, can become ill following swimming or playing in impacted

recreational waters. A rise in either nitrogen or phosphate is believed to be primary nutrients supporting

the algal blooms. The ISDH Chemistry Laboratory is now assisting IDEM by providing low-level analysis of

dissolved reactive phosphate. Specifically, dissolved reactive phosphorus was added to the list of

requested analytes for 12 sites from two northern Indiana routes for the “fixed” station monitoring that

we do for IDEM. With support from IDEM, the Chemistry Laboratory was able to purchase new

instrumentation for this testing that helps protect our drinking and surface waters.

1. https://www.epa.gov/nutrient-policy-data/cyanobacterial-harmful-algal-blooms-water

16

BIOLOGICAL PREPAREDNESS AND OUTREACH

Rabies

“Dogs suffer from three diseases; these are named Rabies, Dog-strangles, and Foot-ill. Of these, Rabies

produces madness, and when Rabies develops in all animals that a dog has bitten, except man; it kills

them; and this disease kills the dogs too.”

-Aristotle, History of Animals

Rabies, a Latin word for “madness, rage, fury,” has been

described plaguing both man and animal since at least the

fourth century B.C. Caused by the lyssavirus, infections affect

the central nervous system and, without treatment, will result in

death. Louis Pasteur developed the first successful human

vaccine in 1885, and this disease still remains vaccine-

preventable in both humans and other mammals. Accurate

and rapid diagnostic testing is also necessary for exposed

individuals to receive required, post-exposure prophylaxis.

The ISDHL is the only laboratory in the state performing rabies

testing on animal specimens. Rabies is diagnosed by a direct

fluorescent antibody test (DFA), amplification method, or histologic/immunohistochemistry

examination. ISDHL currently tests only animal specimens with the DFA test.

As highlighted above, laboratory test results are a critical step for preventing this fatal disease. As in all

testing areas, ISDHL strives to excel in providing accurate, reliable, and timely test results. In

conjunction with the internal audits ISDHL performs, the Rabies Lab was audited by an external

organization and was the first rabies laboratory in the U.S. to achieve ISO 17025 accreditation!

DFA positive result for rabies virus antigens (CDC PH Image Library)

TEM of rabies virions in tissue sample (CDC PH Image Library)

Rabid dog (CDC PH Image Library)

17

“Other” Animals Tested for Rabies:

Animal #’s Animal #’s Animal #’s

Camel 1 Goat 2 Opossum 8

Cow 3 Groundhog 4 Pig 2

Coyote 5 Horse 5 Rat 1

Deer 1 Mink 2 Sheep 3

Donkey 1 Mouse 1 Skunk 6

Fox 3 Muskrat 2 Squirrel 2

425

240

394

57 52

Animal Species Submitted for Rabies Testing in 2017

Bat Cat Dog Raccoon Other

18

Biological Preparedness Laboratory

In addition to rabies testing, the Biological Preparedness, Laboratory

Outreach, and Logistics (BPLOL) Division at ISDHL also serves as a Laboratory

Response Network (LRN) reference laboratory for confirmation testing of

potential bioterrorism agents and tested 16 isolates and one suspicious

environmental sample with LRN-B procedures in 2017. Our biosafety officer

conducted biosafety risk assessment lab training visits at 29 clinical

laboratories and served as a great resource for biosafety-related questions

from these clinical laboratories. Each of the visited clinical laboratories

completed at least one biosafety risk assessment in their labs.

Outreach and Training

The Outreach and Training Team, under the BPLOL Division, was engaged in 37 events, educating 236

external partners, in 2017. The team coordinated and presented trainings such as the ever-popular

Biothreats 101 Course, Phlebotomy, Division 6.2 Packaging and Shipping, Carbapenemase Producing-

Carbapenem Resistant Enterobacteriaceae, Blood Lead & Case Management, First Responder

Environmental Sample Collection, the Local Health

Departments’ Environmental Health Specialist

(EHS)/Public Health Nurses (PHN) Orientation, and

others.

In addition, the Outreach and Training Team hosts

vendor booths at a variety of events. Events in 2017

included the ISDH Public Health Nurse’s Conference;

Chemical, Biological, Radiological and Nuclear

(CBRNe) World Conference; Indiana Environmental

Health Association (IEHA); Indiana Water Works

Association (InAWWA); and Indiana Emergency

Response Conference (IERC). The team attends and

hosts vendor booths at other events as needed.

Dr. Sara Blosser conducting a CP-CRE

Training for Indiana Laboratories

19

Other outreach activities include responding to public health emergencies such as the HIV outbreak in

southern Indiana and the lead contamination situation in northwest Indiana, assisting county health

departments in events such as the Howard County Head Start Blood Lead specimen collection,

presenting on relevant topics at the Public

Health Nurse’s Conference, and attending

Train-the-Trainer and the National Laboratory

Training Conference (NLTC-9) to improve our

training offerings. The team presented posters

on mycology and blood lead trainings at the

annual meetings for the American Society for

Microbiology (ASM) and the Association of

Public Health Laboratories (APHL),

respectively; the team also serves on the

Board of Directors for the South Central

Association for Clinical Microbiology (SCACM).

Jyl Madlem conducting a Phlebotomy

training for Indiana public health

nurses

Shelley Matheson (ISDH Laboratories) and Jeff Larmore

(Marion County Public Health Department) conducting a

training for Indiana first responders

20

ENVIRONMENTAL MICROBIOLOGY

In April 2017, ISDH was chosen to host FDA’s annual Laboratory

Examination of Dairy Products course. FDA uses these annual training

sessions to provide important information to the state and private

sector labs to ensure consistent, high-quality dairy testing. Such dairy

testing is federally required as part of routine surveillance. This two-

and-a-half-day course was attended by 26 people training to either

test products in a private sector dairy lab or become a state laboratory evaluation officer (LEO).

Lectures and wet lab sessions focused on the methods in which FDA and state LEOs certify individual

laboratorians. Weeks of intense planning were required to coordinate FDA supply orders, sample

preparation, attendee registration, food and beverage logistics, course handouts, and vendors’

product information.

Housed with the Food Microbiology Laboratory, dairy testing includes evaluating dairy products with

multiple methods for antibiotic residues, confirming the percentage of fat present in the dairy product,

and testing the products for the presence of bacteria such as E. coli and Staphylococcus species.

Food Microbiology also tests other food and meat products related to consumer complaints and

potential foodborne illness/outbreaks or as part of federally required routine surveillance activities.

Partnering with BOAH, the ISDH Food Protection Program (FPP), and LHDs, ISDHL’s Food Microbiology

completed 15,065 tests in 2017 to support such partnerships. As an entire division, Environmental

Microbiology completed 36,594 tests in 2017 in support of multiple programs and agencies including

the CDC, the Environmental Public Health Division (EPHD), the Epidemiology Resource Center (ERC),

IDEM, and private citizens.

0

2000

4000

6000

8000

10000

12000

14000

BOAH CDC EPHD ERC FPP IDEM LHD Private

2017 Environmental Microbiology Testing

Food Water Enterics

21

VIROLOGY/SEROLOGY The ISDHL Virology and Serology Division tests human specimens for mosquito-borne diseases, including

Zika, chikungunya, and dengue, through serological and molecular methods. In 2017 serological

testing for Zika resulted in four positive specimens and 423 negative specimens. Using molecular testing

methods, 183 specimens were evaluated in 2017 with two specimens positive for dengue; 49 negative

for Zika, chikungunya, and dengue; and 132 negative for Zika only. In conjunction with the Biological

Preparedness and Outreach Division, ISDHL also tested mosquito pools for West Nile virus (WNV), St.

Louis Encephalitis (SLE), and Eastern Equine Encephalitis (EEE) as part of active surveillance activities in

partnership with ISDH Vectorborne Epidemiology.

In 2017, there were 2,137 mosquito pools that were tested, with 499 pools in 90 of 92 Indiana counties

positive for WNV. No mosquito pools in 2017 were positive for either SLE or EEE.

Testing approximately 46,000 specimens annually, the Virology and Serology Division also tests for

several microorganisms of public health importance including hepatitis, HIV, syphilis, and influenza.

*MISC: Measles, Mumps, Rubella, Hepatitis B, HSV, VZV, Enterovirus

19179

18356

6060

1225 610 912

2017 Virology and Serology Testing

HIV Hep C Syphilis Influenza Zika MISC

22

2017: The Year in Mosquitos

Nothing beckons the call of the beginning of summer as that first mosquito bite of the season. With

over 3,500+ species, these prehistoric bloodsuckers (and only the females draw a blood meal) are

easily the most successful transmitters of disease worldwide. Although mosquitoes live only days

(males) to a few months (females), these resourceful and hardy insects are able to breed in limited

amounts of stagnant water, are gaining resistance to insecticides, and are also expanding their

habitat ranges due to climate changes while vector control programs lack capacity for adequate

abatement.1 More than just a pesky creature that can ruin any outdoor activity, mosquitoes can

spread a laundry list of diseases including Zika, WNV, chikungunya, yellow fever, dengue, malaria, La

Crosse Encephalitis (LAC), Western Equine Encephalitis (WEE), EEE, SLE, California Encephalitis (CE),

Jamestown Canyon virus, and dog heartworm (Dirofilaria immitis). Here in Indiana, the dominant

species of mosquitoes that are trapped and tested for disease include:

Culex pipiens and Culex restuans (WNV, SLE)

Aedes albopictus (WNV, SLE, LAC, dengue, chikungunya, Zika)

Aedes japonicas (WNV, SLE, LAC, EEE)

Aedes triseriatus (LAC, WNV)

Coquillitidia perturbans (EEE)

Anopheles quadrimaculatus (Malaria)

Anopheles puncitpennis (Malaria)

Aedes vexans (dog heartworm, nuisance biter, possibly a EEE vector but not clear)

C. pipiens (IL Dept. of Public Health) A. albopictus (CDC PHIL/J. Gathany)

A. triseriatus (CDC PHIL/J. Gathany) A. japonicas (CDC PHIL/J. Gathany)

23

CLINICAL MICROBIOLOGY

KPC, VIM, and NDM, oh my!! … The year of persistent resistance and laboratory innovations

More than alphabet soup, antibiotic-resistant organisms remain an ongoing challenge and great

concern of public health. The ISDHL’s Clinical Microbiology Division remains a committed and active

statewide player in identifying these organisms and their resistance mechanisms. From submissions

from our clinical partners, 325 resistant-positive organisms and their resistance mechanisms were

identified in 2017.

To increase the success of a correct identification, the Assay Development branch of the Clinical

Microbiology Division developed several assays and validated new testing equipment, including:

A mcr-1/mcr-2 multiplex PCR: Previously ISDHL had validated mcr-1 PCR to detect this

emerging mechanism of colistin resistance; mcr-2 was added in 2017.

Sensititre Gram Negative Broth Microdilution Assay: Expanded antibiotic susceptibility testing

capabilities were added.

0 50 100 150 200 250 300

C. freundii

E. cloacae complex

E. coli

K. pneumoniae

Serratia marcescens

P. aeruginosa

Other

2017 Identified Resistant Organisms

KPC VIM NDM OXA 48-like Novel

24

BioMIC: A digital imaging system for use in reading Kirby Bauer Antibiotic Susceptibility Test

(AST) results versus AST results manually, which is time-intensive.

MALDI-TOF MS for Reference Bacteriology isolates: This validation tested almost 200 isolates

from the ISDHL freezer and was able to greatly expand the number of species validated at

ISDH.

Upgrades for Bruker RUO for the MALDI-TOF MS: New library upgrades were released by Bruker

Daltonics. To continue testing using the new library, a data validation was completed,

documented, and signed off by the laboratory director.

Bruker FDA-approved CA System for the MALDI-TOF MS (in progress): A new library upgrade

was released by Bruker Daltonics. As this system is FDA approved, the assay must be re-verified

to continue testing using the new library.

A significant contribution to the success of the Clinical Microbiology Division (and other divisions) to

effectively develop or validate new testing was the creation of ISDHL’s Validation Team in 2016 and

subsequent validation team charter in 2017. Consisting of the Director of Quality Assurance (QA), the

Director of Clinical Microbiology, and the Assay Development Supervisor, the primary goal of this

group is to provide clear guidance and guidelines for assay validations, verifications, and method

comparisons at the ISDHL. The Director of QA determines whether a proposed project plan meets the

criteria outlined by CLIA, or other governing body, and looks for possible areas of weakness in the

validation/verification from a QA perspective. The Assay Development Supervisor provides technical

expertise regarding the lab work or study design. The Director of Clinical Microbiology provides

expertise in both the technical aspects as well as QA, thus bridging the gap between technical and

QA review. This team has developed a process for undertaking a validation, verification, method

comparison, or addendum at ISDHL, including templates for each step of the process of the project

plan. Prior to beginning a project, the team proposing the project writes a study plan and presents it to

the Validation Team. This study plan outlines the use and justification of the assay; the cost analysis of

the assay, including the total cost of the validation; and the validation strategy, including an isolate

list, validation timeline, type of samples, range of results, acceptable limits, and discrepancy analysis.

After approval is received from the Validation Team, the proposing team is free to begin the project.

After the project is complete, the proposing team writes up the validation/verification/addendum/

method comparison paperwork and submits it to the Validation Team for review. The Validation Team

reviews the document for data integrity, sensitivity, specificity, and cohesiveness of overall writing, with

the goal to provide strong documents that will provide not only auditors, but also the ISDH Laboratory

Director and future employees with clear reasoning for the conclusions reached by the validation

testing. All documents (plan, write-up, approved validation) are kept on the ISDHL SharePoint QA site,

and all ISDHL employees have access to these documents in this location. By creating a validation

team, the ISDHL has established a process that creates continuity between departments. By writing a

study plan, departments save money on validations because troubleshooting steps and specimen lists

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are prepared ahead of time, eliminating the need to run additional specimens when problems arise.

This level of planning also eliminates interpretation bias and excessive retesting, which are red flags for

QA and auditors. In 2017, the Validation Team reviewed proposals and/or validation write-ups for a

total of 26 projects.

Beyond testing for antibiotic-resistant organisms, other testing from the Clinical Microbiology Division

totaled 21,590 tests and included:

*TB DST panels = Mycobacterium tuberculosis drug-susceptibility testing panel

1030

174

15565

2130

2130

491

70

0 2000 4000 6000 8000 10000 12000 14000 16000 18000

Bacteriology

Mycology

CTGC

TB smears

TB cultures

TB identification

TB DST panels*

2017 Clinical Microbiology Testing

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QUALITY ASSURANCE ISDH Laboratories Collaboration with ASM/CDC’s Global Fellowship Program

During the week of September 18, 2017, ISDH

Laboratories Quality Assurance (QA) Director Chris

Grimes hosted seven public health laboratory QA

officers and directors from three countries that have

been the focus of this ongoing collaboration:

Armenia, Kazakhstan, and Georgia. These countries

were selected to support the ongoing efforts of the

U.S. Defense Threat Reduction Agency (DTRA) in that

region. To improve public health infrastructure,

fellowships were offered to pivotal individuals, so

they could travel to the ISDH Laboratories to learn how to better implement laboratory QA policies

and procedures, how to improve laboratory safety, and how to achieve accreditation for their public

health laboratories.

ISDH Laboratories welcomed the ASM/CDC global fellows and their CDC escorts with open arms. We

provided them with in-depth demonstrations of our internal audit processes, document control, non-

conforming event reporting, and overall QA/safety policies, as well as a visit to the City Market and

Farmers’ Market. Previously, whenever ASM/CDC global fellows return home from their sessions at ISDH

Laboratories, they have made significant improvements in their national laboratory networks and

public health laboratory quality systems.

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PROTECTING THE HEALTH OF HOOSIERS One Test at a Time

Indiana State Department of Health Laboratories

550 West 16th Street, Suite B

Indianapolis, IN 46202

Phone: 317.921.5500

Fax: 317.927.7801

Email: [email protected]

Website: http://www.in.gov/isdh/22421.htm

Our Mission

To promote, protect, and improve the health and safety of all Hoosiers

Our Vision

A healthier and safer Indiana